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Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial.

Authors :
Norgren L
Patel MR
Hiatt WR
Wojdyla DM
Fowkes FGR
Baumgartner I
Mahaffey KW
Berger JS
Jones WS
Katona BG
Held P
Blomster JI
Rockhold FW
Björck M
Source :
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery [Eur J Vasc Endovasc Surg] 2018 Jan; Vol. 55 (1), pp. 109-117. Date of Electronic Publication: 2017 Dec 20.
Publication Year :
2018

Abstract

Objectives: Critical limb ischaemia (CLI) implies an increased risk of cardiovascular morbidity and mortality, and the optimal antithrombotic treatment is not established.<br />Design, Materials, Methods: The EUCLID trial investigated the effect of monotherapy with ticagrelor versus clopidogrel in 13,885 patients with peripheral artery disease (PAD); the primary endpoint was cardiovascular death, myocardial infarction, or ischaemic stroke. Patients planned for revascularisation or amputation within 3 months, were excluded. This analysis focuses on the subgroup with CLI, defined by rest pain (58.8%), major (9.0%) or minor (32.2%) tissue loss.<br />Results: In EUCLID, 643 patients (4.6%) had CLI at baseline. Diabetes mellitus was more common in the CLI group, while coronary disease, carotid disease, and hypertension were more common in the non-CLI group. A majority of CLI patients (62.1%) had only lower extremity PAD. In patients enrolled on the ankle brachial index (ABI) criteria, ABI was 0.55 ± 0.21 (mean ± SD) for those with CLI versus 0.63 ± 0.15 for those without CLI. The primary efficacy endpoint significantly increased among patients with CLI compared with those without CLI with a rate of 8.85 versus 4.28/100 patient years (adjusted for baseline characteristics hazard ratio [HR] 1.43 [95% CI 1.16-1.76]; p = 0.0009). When acute limb ischaemia requiring hospitalisation was added to the model, significant differences remained (adjusted HR 1.38, [95% CI 1.13-1.69]; p = 0.0016). The 1 year mortality was 8.9%. A trend towards increased lower limb revascularisation among those with CLI was observed. Bleeding (TIMI major, fatal, intracranial) did not differ between those with and without CLI.<br />Conclusions: Nearly 5% of patients enrolled in EUCLID had CLI at baseline. Milder forms of CLI dominated, a result of the trial design. Patients with CLI had a significantly higher rate of cardiovascular mortality and morbidity versus those without CLI. Further efforts are required to reduce the risk of cardiovascular events in PAD, especially in patients with CLI. CLINICALTRIALS.GOV: NCT01732822.<br /> (Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Details

Language :
English
ISSN :
1532-2165
Volume :
55
Issue :
1
Database :
MEDLINE
Journal :
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
Publication Type :
Academic Journal
Accession number :
29273390
Full Text :
https://doi.org/10.1016/j.ejvs.2017.11.006